FDA and pharma urged to cooperate on BTC drugs

Plans by the US Food and Drug Administration to develop a “behind-the-counter” (BTC) or “pharmacist” class of medicines, between prescription and non-prescription or over-the-counter (OTC) status, may have been put in jeopardy by recent legislation.

In 2007 the agency reintroduced the concept of establishing a third drug class - having several times in the past explored the idea but always declining to proceed - holding a public meeting to discuss the public health benefits and beginning work on a formal guidance. However, provisions of the 2007 Food and Drug Amendments Act (FDAAA) which authorise the agency to impose conditions and restrictions on the dispensing of drugs would appear to prohibit the development of such guidance. For example, the Act includes a Risk Evaluation and Mitigation Strategy (REMS) requiring drugs to be dispensed only in “certain health care settings” such as hospitals, and also says that a medicine should be dispensed only “with evidence or other documentation of safe-use conditions, such as laboratory test results.”

It is unlikely that a drug could meet these requirements and also be eligible for non-prescription status, say experts. However, issues such as the FDA’s rejection of Merck & Co’s application for its cholesterol-lowerer Mevacor Daily (lovastatin) to be switched from prescription to OTC status have pointed up the need for a third class of drugs, available without prescription but backed up with pharmacist advice. As well as statins, other potential candidates for BTC status could include allergy medications.

In March 2007, FDA Commissioner Andrew von Eschenbach called on manufacturers to work with the agency to develop a regulatory pathway for BTC drugs, and now, with public opinion clearly favouring such a route but no guidance in place, industry input in the form of proposals for BTC-status medicines could be the way forward in developing the pathway, experts believe.

The American Pharmacists Association (APhA) strongly supports the establishment of a BTC class. “As consumers have become more aware of product risks, they are asking for more and better information to make decisions about their health care needs. Making some medications available after pharmacist intervention could increase available therapy options, improve therapeutic outcomes and enhance patient safety,” says APhA president Winnie Landis.

Moreover, studies show that compliance, safety and health outcomes increase significantly when pharmacists assess and assist patients in managing their prescription and non-prescription medications, says the APhA. With increased access to medications, combined with a pharmacist intervention, a patient is less likely to go untreated or incorrectly treated, it adds.

However, in June the American Medical Association (AMA) reaffirmed its opposition to BTC availability of medicines at its House of Delegates meeting. “Such a process may be out of the realm of a pharmacist's training and might affect patient safety and quality of care,” said the AMA.

- Back in 1995, the US Government Accountability Office (GAO) examined BTC distribution in 10 countries and in the European Union and concluded that the value of a pharmacist-controlled class of drugs “has yet to be demonstrated.” Earlier this year, the House Energy and Commerce Committee asked the GAO to update its study.